Drug updated on 9/4/2024
Dosage Form | Tablet (oral; 60 mg) |
Drug Class | Estrogen agonists/antagonists |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- For the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause.
- For the treatment of moderate to severe vaginal dryness, a symptom of vulvar and vaginal atrophy, due to menopause.
Latest News
Summary
- Osphena (ospemifene) is indicated for the treatment of moderate to severe dyspareunia and moderate to severe vaginal dryness, symptoms of vulvar and vaginal atrophy due to menopause.
- This summary is based on the review of three systematic review(s)/meta-analysis(es). [1-3]
- Ospemifene demonstrated comparable efficacy to other active therapies for treating moderate to severe postmenopausal vulvovaginal atrophy (VVA), with no statistically significant differences observed in most efficacy outcomes, including changes in superficial and parabasal cells, vaginal pH, and the most bothersome symptom of vaginal dryness or dyspareunia.
- Among breast cancer survivors with VVA symptoms, ospemifene did not show an increased risk of breast cancer recurrence; however, the effectiveness of ospemifene relative to other hormonal treatments in terms of symptom relief was not explicitly compared.
- In the context of sexual dysfunction and vaginal atrophy in postmenopausal women, ospemifene's efficacy was not specifically compared to other treatments, and no direct comparative effectiveness data were provided in the systematic review.
- Ospemifene demonstrated no statistical difference in safety outcomes compared to other active therapies for postmenopausal women with VVA, with posttreatment endometrial thickness values remaining below the clinical threshold of 4 mm, and no cases of endometrial carcinoma or hyperplasia observed in trials up to 52 weeks.
- Among breast cancer survivors, ospemifene did not increase the risk of breast cancer recurrence, though the safety data, particularly concerning patients on aromatase inhibitors, is limited and requires further investigation.
- There is no population types or subgroups information available in the reviewed studies.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Osphena (ospemifene) Prescribing Information. | 2023 | Duchesnay USA, Inc., Bryn Mawr, PA |
Systematic Reviews / Meta-Analyses
Document Title | Year | Source |
---|---|---|
Efficacy, tolerability, and endometrial safety of ospemifene compared with current therapies for the treatment of vulvovaginal atrophy: a systematic literature review and network meta-analysis. | 2023 | Menopause: The Journal of the North American Menopause Society |
Safety and Serum Estradiol Levels in Hormonal Treatments for Vulvovaginal Atrophy in Breast Cancer Survivors: A Systematic Review and Meta-Analysis. | 2023 | Clinical Breast Cancer |
Efficacy of Hormonal and Nonhormonal Approaches to Vaginal Atrophy and Sexual Dysfunctions in Postmenopausal Women: A Systematic Review. | 2022 | Federação Brasileira de Ginecologia e Obstetrícia |
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
The 2022 hormone therapy position statement of The North American Menopause Society. | 2022 | Menopause |
Management of postmenopausal vulvovaginal atrophy: recommendations of the International Society for the Study of Vulvovaginal Disease. | 2021 | Gynecological Endocrinology |
Guideline No. 422b: Menopause and Genitourinary Health. | 2021 | Journal of Obstetrics and Gynaecology Canada |